EMA Consultation Seeks Feedback on Overhaul of Vaccine Trials

The European Medicines Agency is considering an overhaul of its clinical trial process for vaccines, including updated guidance on comparative immunogenicity studies.

The update to EMA’s 2007 guidance would discuss how to assess results aimed at showing a vaccine is as good as or better than a product already on the market.

The agency is inviting comments through the end of September, and it plans to release draft guidance in the first quarter of 2018. In the meantime, it has issued a draft concept paper for public comment.